CASE 01
Emergency CDISC Study Rescue
Late-stage vendor replacement and recovery of a submission-critical CDISC package.
European CRO · Dermatology · SDTM / ADaM / define.xml
View case →Case Studies
Selected examples of how TUNECT teams support complex clinical development, biometrics and delivery challenges.
CASE 02
Scaling CDISC Delivery for an FDA-Facing Program
High-volume laboratory data, aggressive timelines and embedded FSP delivery.
US-based CRO · Vaccine / biologics · FSP
View case →CASE 03
Principal Biostatistics Rescue: Estimands & ICE
Senior statistical leadership restored during a critical delivery window.
UK-based CRO · Estimands · ICE · ADaM specifications
View case →CASE 04
Recovering Interpretability in a Confounded Trial
Post-DBL statistical recovery when rescue-medication use threatened interpretation.
EU multicenter RCT · ANCOVA · Post-hoc analysis
View case →CASE 05
End-to-End Data Management & Database-Lock Readiness
A representative Data Management lifecycle from EDC setup through lock and archiving.
Data Management · EDC · Cleaning · Reconciliation · DBL
View case →CASE 06
Medical Writing & Protocol Strategy
Integrated scientific, statistical and regulatory review before protocol finalization.
European pharma · Cardiovascular · Protocol strategy
View case →Selected case studies, not an exhaustive project list. Client, Sponsor and study identifiers are anonymized where needed.